In the field of medicine or cosmetics, it is often necessary to determine the content of a bioactive agent in a formulation on the site of use if the bioactive agent is of high toxicity, for example. However, determination of the exact content of a bioactive agent in a formulation can be tedious and complex.
For example, Botox® is a pharmaceutical formulation containing a botulinum toxin, e.g., the toxin Clostridium Botulinum A derived from the bacterium Clostridium botulinum. This formulation is administered by physicians and finds widespread use in cosmetic and therapeutic applications. The botulinum toxin is an extremely potent nerve agent. As such, pharmaceutical preparations contain only minute quantities of the toxin. The Botox A formulation discussed can include: 4.8 nanograms of the protein Clostridium Botulinum A, along with 0.50 milligrams of human serum albumin and 0.90 milligrams of sodium chloride. Due to the very small quantity of toxin found in a Botox® formulation, it would be extremely difficult to measure directly in a clinical setting. Botox® is manufactured as a dry powder in single vials containing 100 units of active toxin, where 1 unit is defined as the LD50 in a mouse. It is stored at −5 degrees C. Before use, physicians dissolve the formulation in saline or water. The quantity of saline or water used varies between 1 and 8 mL. This results in the formation of Botox® solutions of varying concentrations. Currently there is a need for a simple device to measure the number of units of Botox® in a given volume after the Botox® powder form has been dissolved. This would allow independent verification of the potency of dissolved Botox®, which would benefit consumers (since they can compare number of units they are receiving) and assist in internal controls (a third party can verify that the appropriate amount Botox® was injected).
A direct measure of botulinum exists, but is complicated and expensive to use in the clinical setting. In contrast, the measurement of albumin is simple and inexpensive.
Therefore, there is a need for a simple and an accurate measurement of a bioactive agent such as Botox®.
The embodiments described below address se needs and issues.